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Policy and Procedure

Manual

Clinical Simulation Center Policy and Procedure Manual

Administration

Center Access and Availability SIM-1001

Defibrillator and Code Cart Use SIM-1002

Biological Specimens SIM-1003

Observers SIM-1004

Resources

Equipment Acquisition SIM-2001

Equipment Storage and Maintenance SIM-2002

Separation of Simulation Equipment from the Clinical Environment SIM-2003

Resource Scheduling SIM-2004

Standardized Patients SIM-2005

Course Development

Course Intake Process SIM-3001

Course Prioritization Process SIM-3002

Course Review Process SIM-3003

Personnel

Roles and Responsibilities SIM-4001

Instructor and Assessor Evaluation SIM-4002

Quality Improvement

Quality Improvement Process SIM-5000

Course Evaluations SIM-5001

Complaint Resolution SIM-5002

Research

Research Process SIM-6000

Research Committee and Meetings SIM-6001

Investigator and Personnel Requirements SIM-6002

Investigator/Research Self-Assessment SIM-6003

Data Management Policy SIM-6004

Regulatory Documents SIM-6005

Safety

Confidentiality SIM-7001

Psychological and Physical Safety SIM-7002

Medical Emergencies SIM-7003

Non-Medical Emergencies SIM-7004

Data Management

Data Tracking and Management Requirements SIM-8001

Video Recording and Privacy SIM-8002

Center Access and Availability

Clinical Simulation Center Policy Manual Policy Number: SIM-1001

Original: Nov. 2011 Effective: July 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: The PSHMC Clinical Simulation Center is a resource available to the Penn State Hershey Medical Center and the Penn State University College of Medicine. Additionally, the Center is a community resource and is available to as available to support community programs. While the Center attempts to meet all reasonable requests for service, there is a need to define specific Center availability, especially concerning its higher technology resources. DEFINITION: None PROCEDURE/GUIDELINE: Normal Hours of Operation

• Monday through Friday, 7:00 am – 5:00 pm • Simulation Technologist support available • All rooms and resources available for scheduling

Off-hours availability without Simulation Technologist support

• Training Rooms 1 – 10 (including Harvey) • Skills Room • VR Room • Meeting Room A/B • Excludes Conference Room and Debriefing Room (unless scheduled in advance) • All resources with the exception of CAE Healthcare HPS units and the video recording

system

• Can be scheduled with Simulation Technologist set up • Available on a “walk-in” basis (Resources not guaranteed to be in place)

Off-hours Simulation Technologist and Simulation Bay availability

• Simulation Technologist may be assigned to off hour events on a case-by-case basis. Technologist assignment will be coordinated by the Technologist group with Manager input as needed.

• Simulation Bays (A, B, & C) may be scheduled for afterhours use. If user is not proficient with high technology simulators used in the bays, assignment of a Technologist or Technician may be required. Assignment will be coordinated by the Technologist group with Manager input as needed.

REFERENCES: None PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: 7/2013 Revised: 7/2013

Clinical Simulation Center Policy Manual Policy Number: SIM-1001 Center Access and Availability Effective: July 2013

Defibrillator and Code Cart Use


Original: Jan. 2012 Effective: July 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: The Center must provide a safe learning environment. The use of medical equipment, including defibrillators and code carts, in simulated event presents potential hazards that must be managed. The Center recognizes the need for training with real clinical equipment and strives to provide the most up to date clinical equipment for our Center learners. Separation of Center equipment from actual patient care clinical equipment is required. DEFINITION: Clinical Simulation Equipment – Equipment, devices, manikins, part-task trainers, or other devices designed to simulate a patient or part of a patient for the purposes of education or research. Simulated Diagnostic and Therapeutic Devices – Actual or simulated devices used on clinical simulation equipment for the practice of assessment or therapeutic interventions. PROCEDURE/GUIDELINE: All personnel involved in simulation sessions will observe and comply with hospital practice policies regarding the use of defibrillators and code carts. Center Simulated Diagnostic and Therapeutic Devices are “Not for Patient Use.” They are only authorized for simulation and are not intended for patient or clinical use. In situ training conducted in clinical environments poses a particular risk. In order to eliminate exposure of Center Simulated Diagnostic and Therapeutic Devices in the actual clinical area, Center equipment should not be taken into clinical areas. The use of defibrillators and code carts should be scheduled in the Center, Lecture Rooms or other classroom spaces within the BMR or the College Science wing, or classrooms in the hospital that are separate from outpatient or inpatient clinical areas.

REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, f, v. PERSON RESPONSIBLE FOR REVIEW OF POLICY:

Manager, Clinical Simulation Center

Reviewed: 7/2013

Revised: 7/2013

Clinical Simulation Center Policy Manual Policy Number: SIM-1002 Defibrillator and Code Cart Use Effective: July 2013

Biological Specimens


Original: Effective: June 2016 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: Some simulations can be performed using animal parts because they can provide the feel of real tissue, a feature commercial simulators may have difficulty replicating. Using animal tissues or parts in the Clinical Simulation Center is permissible and consistent with Penn State Hershey Research Administration policies. DEFINITION: Animal Tissue - Any animal tissues being used for research and/or teaching either removed from euthanized animals or purchased from local butchers or food store. (From Penn State Hershey Department of Comparative Medicine Standard Operating Procedure 13.8) PROCEDURE/GUIDELINE: Whole animals, live or dead, are not permitted in the Clinical Simulation Center for use in education or research. Animal tissues or parts (including food grade items such as hot dogs) are permitted for use in simulation-based education and research provided the animal tissues or parts meet the requirements of Penn State Hershey Department of Comparative Medicine Standard Operating Procedure 13.8. Center users are expected to demonstrate common sense and good judgment in the storage, transportation, use, and disposal of animals parts used for simulation education or research. This includes considerations for:

• Freshness of the parts – avoid the use of parts with offensive odors that may impact learners or linger in the Center after the simulation is concluded

• Fluids from the parts – avoid parts with excessive fluid drainage that may leak during transport into or through the Center or potentially damage Center equipment

Disposal of parts – Once the simulation is completed, the sponsoring department is responsible for removing the parts from the Center. Parts should be disposed in heavy-duty opaque garbage bags to limit risk of leakage with labeling as required by Penn State Hershey Department of Comparative Medicine Standard Operating Procedure 13.8. Use of red a Biohazard Bag is not permitted. All biological specimens should be disposed of in the marked refrigerator in Comparative Medicine. Other requirements –

- No food or drink allowed in lab area where animal tissue are located - Use of gloves and lab coat required as minimum - Plastic-backed absorbent paper must be used on all work surfaces - All work surfaces will be disinfected with fresh bleach wipes (such as Sani-Wipe® or Sani-

Cloth® germicidal disinfectant wipes) or a 10% bleach mixture. Clean surface with disinfectant. Allow to stand for 3 minutes prior to final wipe down with paper towel.

- Non-disposable instruments that are used will be cleaned using a 10% bleach mixture. Allows instruments to soak for 10 minutes prior to rinsing and drying.

- Hand sanitizer will be present for hand hygiene Some learners may have objections based on personal viewpoints or religious grounds to using animal tissues or parts. The use of animal tissues or parts as a learning tool should be announced to learners prior to the event in order to allow adequate time for alternative learning models or remediation of the objections. Exception: While not directly related to this policy, live animals may have a role in certain Standardized Patient education scenarios that involve therapy or guide animals as part of the educational objectives. The use of therapy or guide animals as part of a Standardized Patient scenario is permissible. REFERENCES: Penn State Hershey – Department of Comparative Medicine, SOP 13.8 https://infonet.pennstatehershey.net/documents/1409502/1409506/SOP+13.8+Disposal+of+Animal+Carcasses+and+Tissues/7157451a-b187-4899-bdf1-7e1d3cfc0167?version=1.0

https://infonet.pennstatehershey.net/documents/1409502/1409506/SOP+13.8+Disposal+of+Animal+Carcasses+and+Tissues/7157451a-b187-4899-bdf1-7e1d3cfc0167?version=1.0

https://infonet.pennstatehershey.net/documents/1409502/1409506/SOP+13.8+Disposal+of+Animal+Carcasses+and+Tissues/7157451a-b187-4899-bdf1-7e1d3cfc0167?version=1.0

PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: ----- Revised: 08/2016

Clinical Simulation Center Policy Manual Policy Number: SIM-1003 Biological Specimens Effective: November 2013


Reviewed: ----- Revised: 12/2015

Clinical Simulation Center Policy Manual Policy Number: SIM-1003 Biological Specimens Effective: November 2013

Equipment Acquisition


Original: April 2011 Effective: July 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: The Sim Center chooses capital and non-capital equipment largely on the recommendation of practicing clinicians. Obtaining their input provides expert evaluation of the equipment’s clinical fidelity, ease of operation, and general educational value. Equipment requests must be prioritized based on need and available funding. DEFINITION: Capital Equipment – The capital equipment threshold at PSHMC is $5,000. Non-capital Equipment – Non-capital equipment includes all equipment costing less than $5,000 per unit. PROCEDURE/GUIDELINE: Recommendations for capital equipment will be prioritized with input from the Simulation Advisory Council (SAC) with final determination made the Director. Recommendations for non-capital equipment will be prioritized with input from either the SAC as a whole or individual simulation faculty with final determination made by the Director and/or Manager. The SIM Center requests that individuals who evaluate simulation equipment, for possible acquisition, complete the Equipment Evaluation Form. Equipment Evaluation Form

\\hersheymed.net\files\SIMCenter\Public\Policies\Financial and Administrative\GuidelineAttachments\EquipmentEvaluation.doc Cost-Sharing of Equipment Purchases between the Sim Center and Clinical Departments A priority of the Sim Center is leveraging its capital budget with cost sharing for equipment purchases with academic departments. Cost sharing is feasible when one or two departments are expected to be primary beneficiaries of a proposed acquisition. As a partner, the Sim Center assumes responsibility for continuing care and maintenance, as well as the cost of warranties. Cost sharing makes possible simulation equipment that the Sim Center cannot acquire on its own. Note: If the Sim Center is responsible for maintaining a piece of equipment and scheduling its use, then it will be located in the Center and available to all users. REFERENCES: None PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: 7/2013

Revised: 7/2013

Clinical Simulation Center Policy Manual Policy Number: SIM-2001 Equipment Acquisition Effective: July 2013

Equipment Storage and Maintenance


Original: Effective: July 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: The inventory of clinical patient simulation equipment is critical to achieving the mission of the Clinical Simulation Center. This equipment is frequently technologically advanced, may be fragile, and often expensive. Care of this equipment through proper storage and maintenance is essential. DEFINITION: Clinical Simulation Equipment – Equipment, devices, manikins, part-task trainers, or other devices designed to simulate a patient or part of a patient for the purposes of education or research. Simulated Diagnostic and Therapeutic Devices – Actual or simulated devices used on clinical simulation equipment for the practice of assessment or therapeutic interventions. Diagnostic Equipment – Some diagnostic equipment such as stethoscopes, otoscopes, and ophthalmoscope can be used on standardized patients in addition to clinical simulation equipment and must be kept in a patient ready clinical state. PROCEDURE/GUIDELINE: Storage of all clinical simulation equipment as well as simulated diagnostic and therapeutic devices owned or assigned to the Center should adhere to the following points:

• Equipment should be stored in a manner that limits or eliminates the potential for damage.

• When possible, equipment should be stored in its supplied shipping or storage cases.

• Equipment that is left available for use outside of storage cases, should be placed in a location and/or position that limits the potential for damage (such as fall from working surface, exposure to moisture, no impingement from other products or devices).

Simulated Diagnostic and Therapeutic Devices that are not to be used on standardized patients should be labeled “Not For Patient Use” and should not be used in areas where actual patient contact is possible. As appropriate, some simulated diagnostic and therapeutic devices will still require regular Biomedical Engineering checks to ensure operability and safety. Rechargeable battery operated equipment should be connected to electric to maintain charge and readiness for use. Diagnostic Equipment should be kept clean and in a patient ready state. Equipment Maintenance (All types of equipment)

• Warranty covered equipment will follow manufacturer’s recommendations for maintenance including, as applicable, regularly scheduled preventive maintenance servicing.

• Routine servicing of equipment should be conducted following the recommendations of the manufacturer.

• All equipment will be monitored for wear-and-tear use and appropriate repairs will requested through the Center manager.

• At any time a piece of equipment is deemed unserviceable, that equipment may be removed from service. Documentation of service issues will be logged in the Center’s Equipment Database for all equipment tracked through that system. The equipment will also be tagged with an orange Biomedical Engineering Repair Order tag. For clinical equipment that is managed by Biomedical Engineering, normal notification processes will be followed (Policy ME-01SPM).

• Any Center employee can immediately remove from service any equipment that presents as a safety hazard.

REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, f, v. Individual references are available for each piece of clinical simulation equipment.

http://infonet.hmc.psu.edu/policy/Safety/


Reviewed: ----- Revised: Nov. 2013

Clinical Simulation Center Policy Manual Policy Number: SIM-2002 Equipment Storage and Maintenance Effective: July 2013

Separation of Simulation Equipment from the Clinical Environment



PURPOSE: The Clinical Simulation Center uses equipment and supplies that mimic real world product. However, often these products are not compatible with real patient care. Issues such as expired medications, use of distilled water in place of real medications, or medical equipment that is not calibrated for human use are common in simulation. For this reason, simulation diagnostic and therapeutic equipment and supplies must be kept separate from actual clinical areas and efforts must be made to identify not-patient compatible products. DEFINITION: Dedicated Simulation Equipment – Medical equipment that has been dedicated to simulation use and is not intended to be used for actual patient diagnostic use or therapeutic care. PROCEDURE/GUIDELINE: Levels of protection employed in the Center include:

1. Medical equipment used for simulation that has been dedicated to simulation will be labeled “Not for Patient Use.” While this equipment is typically maintained to patient ready status by biomedical engineering, as dedicated simulation equipment it will not be used on real patients.

2. Medications used for simulation will be stored in carts or containers that are clearly

marked “Not for Patient Use.” This includes all code carts assigned to the Center. Medications that are used from departmental stock and not usually stored in properly labeled carts will have individual labeling indicating “Not for Patient Use.”

3. Equipment and supplies dedicated to simulation will not be transported or used in real clinical areas. In Situ simulations should rely on actual patient ready equipment and supplies in the clinical area.

Some medical equipment used by the Center is received on an as needed basis from PSHMC equipment distribution. This equipment is not dedicated solely to simulation and will not be labeled as dedicated simulation equipment. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, f, v. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: ----- Revised: -----

Clinical Simulation Center Policy Manual Policy Number: SIM-2003 Separation of Simulation Equipment from the Clinical Environment Effective: July 2013

Resource Scheduling


Original: Effective: November 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: The PSHMC Clinical Simulation Center has many resources available for faculty, instructors, and learners to reserve to support learning. This includes Center rooms, manikins and simulators, and medical equipment used for simulation. The Center has the responsibility to ensure that these resources are utilized appropriately and available when needed. Additionally, Center support personnel are also resources that must be taken into account for certain reservations. DEFINITION: None PROCEDURE/GUIDELINE: Reservation requests for Center resources may come in from a variety of sources. These may include instructors, course directors, administrative support personnel, or Simulation Educators. In general, reservations are on a first-come-first-served basis. Center scheduling personnel will attempt to resolve conflicts based on alternate equipment and resource options. End resolution of conflicts regarding unavailable reservations is the responsibility of the requesting departments/personnel to negotiate for resource availability. Policy SIM-3002 Course Prioritization should be used as a guide to allocate resources when multiple requests are received. The preferred pathway for reserving resources is through the Course Intake Process as outlined in Policy SIM-3001 so that reserved resources best match the educational objectives of the simulation. This is typically accomplished through the Simulation Technologists.

When faculty have previously developed scenarios or know specific resources needed for simulation (such as task training), resources can be reserved directly with the Center’s Scheduler. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, h, i. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: -----

Revised: -----

Clinical Simulation Center Policy Manual Policy Number: SIM-2004 Resource Scheduling Effective: November 2013

Standardized Patients



PURPOSE: The Penn State Hershey Clinical Simulation Center encourages the use of standardized patients (SPs) to train, assess, and evaluate students and residents, enhancing the quality and effectiveness of clinical education. The Standardized Patient Program, administered and managed in the Office of Medical Education, recruits individuals who are not employed by the hospital, but paid specifically for a pre-arranged time in which they come to the hospital and portray patients for teaching and assessment purposes. DEFINITION: Standardized Patient – A person trained in portraying a patient, family member, or other party involved in a simulation scenario for the purposes of either presenting the case or aiding in its evolvement. PROCEDURE/GUIDELINE: In order to identify individuals that best match the requirements for simulation case scenarios, the Center requests that instructors complete the Request for Standardized Patients This document describes the specific role to be played by standardized patients. In respect for the time it takes to recruit qualified individuals, the Center can only accept requests that are received at least ten business days before their intended simulation session. Request for Standardized Patients in Simulation Sessions \\hersheymed.net\files\SIMCenter\Public\Policies\Financial and Administrative\GuidelineAttachments\RequestForStandardizedPatients.docx REFERENCES:

None PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center



Standardized Patients Effective: July 2013

Course Intake Process



PURPOSE: New course concepts brought to the Center must be coordinated between the Course Director, Content Experts, Simulation Educators, Simulation Technologists, and the Scheduler. To help ensure that all new courses have the best chance of meeting course instructional goals, a process will be in place that follows proven instructional design concepts. Key to this process is the Simulation Educator who has expert knowledge in instructional design and the Simulation Technologist who has expert knowledge in matching educational objectives with the appropriate simulation modality. The Center will follow the instructional design concepts presented by Kern, Thomas, and Hughes (in Curriculum Design for Medical Education: A Six-Step Process, Johns Hopkins University Press, 2009). DEFINITION: Definitions of key personnel are described in Policy SIM-4001 Roles and Responsibilities. PROCEDURE/GUIDELINE: Each new course will have a Course Intake Form completed that addresses developmental questions essential to effective course development and meets the accreditation standards of the Society for Simulation in Healthcare. The Course Intake Form (attachment) will serve as documentation of this process.

Course Intake Process:

Step Event Activity

1 Simulation Center contacted by requester

Initial information (requester name, contact number, general purpose of simulation) is recorded. Simulation Educator is contacted to begin intake process.

2 Simulation Educator contacts requester

Course Director and Content Expert are identified.

3 Simulation Educator contacts Course Director

Course Director contacted to determine educational needs, learner analysis, and instructional goals. If needed, separate Course Content Expert identified to develop objectives and content.

4 Simulation Educator turns course over to Simulation Technologist

Simulation Technologist meets with Course Director and/or Course Content Expert to determine best simulation modality and equipment to achieve objectives.

5 Resources are scheduled Simulation Technologist works with Scheduler to schedule resources

6 Course is piloted or scenario is tested

Simulation Technologist works with Course Director or Course Content Expert to pilot simulation or scenario. Revisions as needed.

7 Course implemented Simulation Technologist and Course Faculty conduct course.

8 Course Evaluation Simulation Educator reviews course evaluations with Course Director to determine if instructional goal is met.

REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 1, b, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 1, e, ii. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 1, f, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 2, c, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 2, e, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 3, b, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 3, c, i.



Clinical Simulation Center Policy Manual Policy Number: SIM-3001 Course Intake Process Effective: November 2013

1

Course Intake Process

When a new course is proposed for the Penn State Hershey Clinical Simulation Center, this form will be completed to provide details about the goals, objectives, and desired outcomes for the course. This document aids in providing essential information to the Center’s educators and technologists to ensure that the objectives are met and to provide necessary documentation of course development as required by the Society for Simulation in Healthcare accreditation process.i Overview Course Name:

Department:

Course Director(s):

Course Director Contact Information:

Others on Planning Committee for Course:

Content Expert (if different from Course Director):

Content Expert Contact Information:

Assigned Educator:

Assigned Technologist:

Is this course part of a research project: Yes No

Course Category: Select one only

Faculty Education Other Education Program Fellow Education PA Student Program Graduate Student Education Outreach Education Instructor Development Research Medical Student Education Resident Education Nursing Department Education RSTC Nursing School (Non-PSU) Team Training Nursing School (PSU)

Target Date for First Course:

Target Schedule: One time event Monthly Short term series Quarterly Irregular Annually Weekly As requested Bi-weekly Other____________________________

2

Section 1: To be completed by Simulation Educator in coordination with course director or content expert Step 1: Problem Identification and General Needs Assessment

What healthcare need does this curriculum address? What is the impact on patients, healthcare professionals, and/or society? Select the general category of impact (may select more than one).

Clinical outcomes Medical and nonmedical costs Quality of life Patient and provider satisfaction Quality of healthcare Work and productivity Use of healthcare and other resources Societal function

What is the current state? What is the ideal state? General needs analysis (difference between current state and ideal state: describe the learning gap in knowledge, skills, or practice) Source of needs analysis information (Check all that apply)

Observed performance deficits Improve ability in achieving local or organizational performance metrics such as mortality and

morbidity, serious safety events, or other patient related outcomes New procedures, medications, equipment, locations, or processes New knowledge (such as protocol changes) Regulatory and accreditation requirements Organizational goals or initiatives Learner self-assessment of personal education needs (surveys or focus groups) Improve educational methodology of existing course Improve employee, student, or medical staff recruitment, satisfaction, and retention Expert opinion Research specific goal (testing new device or procedure) User request Other:

Step 2: Needs Assessment for Targeted Learners

Who are the targeted learners for this curriculum?

Single discipline (i.e. all physicians) Multidisciplinary (i.e. mixed teams) How is an educational intervention targeting this group going to solve the healthcare problem?

3

Learner analysis (comment on the following):

What is the targeted learners’ current level of training and education regarding this need? Does this group have a preferential learning style? Does this group face any barriers to learning or have any enabling or reinforcing factors? What resources are available to the targeted learners regarding this need?

Step 3: Goals and Objectives

Instructional Goal: What is the desired overall end result for this course?

Is this goal linked to organizational strategic goals? Yes No

Explain how it is linked or explain why this link is not needed. Terminal Objectives (Section or Station level objectives – if different than overall instructional goal): Learner Objectives (Specific cognitive (knowledge), psychomotor (skill and behavioral), or affective (attitudinal) objectives. Define one set of objectives for each station, class, or content area being addressed): 1. 2. 3.

A Note About Objectives Objectives need to be specific and measurable. There are five components to an objective:

1. Audience – Who will be the target of the learning event? It could be an individual or a team.

2. Behavior – The most basic definition of learning is a change in behavior brought about by an educational intervention. Behavior is the observable actions of the learner. The objective must define the specific behavior to be changed. An action verb indicates the desired behavior in the objective.

3. Condition – The context of the educational intervention must be defined. This part of the objective states under what conditions the behavior will be identified.

4. Degree – All behaviors must be measureable. Degree defines the level of precision in achieving the desired behavior.

5. End Time – When will the objective need to be completed? By the end of the class session, end of the semester, after first patient encounter, etc.?

4

Outcome Objectives desired (single sentence stating what health, healthcare, and patient outcomes are to be achieved): Assessment Strategy – What method will be used to determine if the instructional goal and/or objectives were achieved (check all that apply)?

Written evaluation Expert observation in a simulated setting Checklist completed during simulation Expert observation in a clinical setting Checklist completed during a clinical encounter Other: Change in performance metrics (i.e. reduced infection rates, decreased procedure time, improved

patient satisfaction, etc.) Will assessment be conducted at the team or individual level? Team Individual Step 4: Educational strategies

Is simulation the best educational strategy to achieve the goal and objectives? Yes No

Explain why or select from list below. Check all that apply:

Objectives are higher level objectives (Application level or higher) Simulator able to provide necessary fidelity to meet objectives Learning objectives require some level of experimentation on the part of the learners Learning objectives include testing systems capabilities Learning objectives require a contextual application of knowledge and skills Active reflection (debriefing) essential to meeting objectives and reinforcing learning Learners expected to respond better in an active learning environment Group interaction and communications are key objectives

Beyond the simulation scenario(s), will other learning materials need to be developed? Yes No

If yes, what materials need to be developed (i.e., workbooks, slide presentations, etc.)?

Section 2: To be completed by simulation technologist in coordination with the course director or content expert

Step 5: Implementation

What type of simulation should be used (If the course involves multiple learning stations, define best mode of simulation for each learning station)? Check all that apply.

High technology manikin (such as HPS) Mid-level technology manikin (such as Skills Reporter) Low technology manikin (such as a Crash Kelly or Stella) Standardized patient or other actor Task trainer (such as IV insertion trainer) Hybrid simulation (such as real person combined with task trainer) Virtual skills trainer (such as Accutouch or LSAT) Screen-based simulator (Such as AHA Online PALS) Other: _______________________________________________________________________

5

The simulation technologist in cooperation with the course director or content expert will:

• Develop required scenarios that address the learning objectives • Create an equipment and supplies set up list for the scenario • Test/pilot the scenario (a scheduled walk-through) • Revise the scenario based on the initial pilot • Schedule the scenario with appropriate room and resources, including simulators, other

equipment (IV pumps, code cart, defibrillator, etc.), disposable supplies, and personnel • Implement the scenario in the educational intervention • Solicit or provide process/implementation feedback for simulation activity

Section 3: To be completed by simulation educator in coordination with course director or content expert

Step 6: Evaluation and Feedback Upon completion of this course, how will the curriculum be evaluated to determine how it met the needs of the learners (check all that apply)?

Learner evaluation form Expert observation Faculty evaluation form Manager or Supervisor feedback Group discussion/debriefing Focus group Other: ______________________________

i This process is based on Kern DE, et al: Curriculum Development for Medical Education – A Six-Step Approach. Baltimore: The Johns Hopkins Univ. Press. 2009 (2nd edition). Developed June 2013 DLR/SJR Job Aid Supporting Clinical Simulation Center Policy SIM-3001 Course Intake Process

Course Prioritization



PURPOSE: While the goal of the Clinical Simulation Center is to provide support and opportunities for all requested users, there may be times when workload demands some level of prioritization of Center resources (both equipment and personnel). At these times, prioritization of resource allocation must be activated. DEFINITION: None PROCEDURE/GUIDELINE: The Center maintains the standard that all appropriate requests for course development will be addressed by Center staff. On occasions when development demand exceeds the Center’s capacity to address all requests, the following prioritization patterns will be implemented at the direction of the Manager or Director: Priority 1 Courses that have the potential for immediate impact on a patient safety issue Priority 2 Courses that have the potential for immediate impact on personnel readiness Priority 3 Courses that are directly linked to the organization’s strategic plan Priority 4 Other internal (COM/PSHMC) courses Priority 5 Revenue producing external courses Priority 6 Non-revenue producing external courses Center resources are reserved on a first come/first saved basis. Because the Center has a large inventory of simulation equipment, a large physical facility, and the additional space resources of the COM and the PSHMC, when conflicts arise there are often alternative pathways to meet

client needs. When conflicts arise, Center staff (Scheduler or Simulation Technologist) will mitigate the conflicts by working with the clients to identify alternative resources and suggest options to mutually satisfy all parties involved. In the event front line Center staff cannot resolve the conflict to the mutual satisfaction of all parties, the Manager or Director will be notified and they will be responsible for final resolution. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, h, i. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-3002 Course Prioritization Effective: July 2013

Roles and Responsibilities



PURPOSE: Within the Clinical Simulation Center there are many specific tasks that must be performed in order to maintain the Center’s operations and its ability to meet it mission obligations. Some of these roles are detailed in job descriptions while others are more informal or represent committees that have responsibilities to the Center. The purpose of this policy is to provide an overview on essential roles and responsibilities for most positions or committees that have a role within the Center. DEFINITION: Simulation Advisory Council – The Simulation Advisory Council (SAC) is an open membership committee representing simulation faculty and users from across the organization. It is a multidisciplinary and multiprofessional group that provides strategic and operational oversight of the Center. Specific responsibilities include:

• Approves policies and procedures for the Center • Provides input and guidance in capital equipment requests • Provides input and guidance in operating budget and equipment acquisitions • Serves as a focus group for continued Center development • Members actively support the integration of simulation into various curricula across the

organization Research Review Committee – Defined in Policy SIM-6001, the Research Review Committee provides oversight to the research activities of the Center by providing feedback to investigators during proposal development, aggregating all simulation-based research in the organization, and disseminating reports on simulation-based research activity.

Director – The Director of the Clinical Simulation Center is defined in a specific job description. General overview of the position of the position is to provide strategic direction for the Center, serves as the primary liaison for the Center to other entities both within the PSHMC and PSU system and external to the organization, and provides final approval for all operational plans. Director of Surgical Simulation – The Director of Surgical Simulation is the primary liaison with the American College of Surgeons (ACS) and is responsible for coordinating and validating the standards required of the Center for maintenance of the Center’s ACS Educational Institute status. Director of Simulation Research – The Director of Simulation Research is defined in a specific job description. General overview of the position is to chair the Research Review Committee, coordinate simulation research within the Center, and serve as a liaison to other departments both inside and outside the organization on research related topics. Manager – The Manager of the Clinical Simulation Center is defined in a specific job description. General overview of the position is to provide daily operational support the Center including management of budget, personnel, equipment and inventory, administrative issues, policies and procedures, support the Director in strategic planning, and serve as an operational liaison with other departments. Simulation Educator – The Simulation Educator is defined in a specific job description. General overview of the position is to support the Center by serving as an educational expert in the development of simulation-based while interfacing with Course Director and Course Content Experts. Additional responsibilities include leading simulation faculty development initiatives within the department. Simulation Technologist – The Simulation Technologists are defined in a specific job description. General overview of the position is to support all Center simulation-based educational activities by working with clients/users to identify the best simulation tools to achieve goals, building scenarios and simulations to meet objectives, managing equipment and resources, conduct simulation sessions, assist in instructional activities as applicable, and support the Manager and/or Director with administrative functions including budget, finance, purchasing, and data management. Scheduler – The Scheduler is defined in a specific job description. General overview of the position is to maintain the Center’s educational event schedule by interacting with clients/users, determine resource needs, scheduling resources, and directing clients/users to other individuals in the department as needed to assist in educational program development. Additionally, the Scheduler supports the Manager and/or Director with administrative functions including budget, finance, purchasing, and data management.

Project Manager – The Center may employ specialized Wage Staff personnel for the role of Project Manager. This position is flexible according to departmental needs and goals and may include research support, administrative support, or special projects coordination. Wage Staff – Wage Staff are part time Simulation Technicians who support Center activity by supplying technical support to clients/users on an as needed basis. Course Director – The Course Director is the individual responsible for all key decisions regarding an individual educational course. This person may or may not actually teach the course. Course Content Expert – The Course Content Expert is the individual who is expert on the course content and can assist the Simulation Educator or Simulation Technologist with development of the simulation scenario or educational product. The Course Content Expert and the Course Director may frequently be the same individual. Course Contact – The Course Contact is the individual who coordinates times and other resources on behalf of the Course Director. Typically this is an administrative person and is not a decision maker regarding course goals and objectives. Simulation Faculty – The Simulation Faculty are the individuals present for the simulation and present the educational program and simulation. Ideally Simulation Faculty have had simulation instructor education and training (such as the PSHMC Clinical Simulation Center Teaching with Simulation course or its equivalent). In lieu of formal training, there is an expectation that faculty are briefed by the Simulation Educator or Simulation Technologist on their role as Simulation Faculty. Clients/Users – Clients and/or users are any individuals who teach as Simulation Faculty, Course Directors, and Course Content experts or participate in simulation-based educational programs. PROCEDURE/GUIDELINE: The definitions outlined in this policy will serve as the universal definitions applied across the department in various databases and in other policies. REFERENCES: None PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-4001 Roles and Responsibilities Effective: November 2013

Quality Improvement Process



PURPOSE: Continuous quality improvement is a hallmark of all organizations that seek to improve outcomes. To this end, the PSHMC Clinical Simulation Center will employ strategies that aim to improve course delivery, simulation faculty capabilities, and learner outcomes. DEFINITION: None PROCEDURE/GUIDELINE: Curriculum Development and Improvement Pre- Session Meeting: For sessions proposed for the first time, or have been modified, instructors are expected to meet with Center Technologist for a planning meeting. At that time, the instructor’s knowledge of curriculum and learning objectives are matched to the Technologist’s knowledge of simulation resources. This process brings together both perspectives, and the highest probability of success and satisfaction. Pre-Session Walk-Through: The Center encourages instructors, especially those with co-instructors, to meet between 30 and 60 minutes before a session to conduct a quick review of roles, sequences, and support from Center staff. Session Satisfaction Survey: Each instructor is encouraged to complete a brief computerized survey of instructor satisfaction that assesses the quality of the session planning, room preparation and setup, and staff support. The surveys are available on the hallway computers.

Post-Session Instructor Debrief: A one-minute mini-debriefing between session instructors and Center staff is encouraged following each session. This meeting makes staff aware of faculty suggestions or concerns that will improve future sessions. Annual Curriculum Review Instructors are asked to annually review their simulation curriculum with regard to learning theory or educational methodology, peer review, and learner feedback. Faculty Teaching Agreement \\hersheymed.net\files\SIMCenter\Public\Policies\Sessions and Curriculum\FacultyTeachingAgreement.wbk REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, f, ii. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 4, b, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Teaching and Education Standards, Section 5, f, v. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: 7/2013

Revised: 7/2013

Clinical Simulation Center Policy Manual Policy Number: SIM-5000 Quality Improvement Process Effective: July 2013

Complaint Resolution



PURPOSE: Service Excellence is a key goal for all PSHMC departments. The PSHMC Clinical Simulation Center aims to have all simulation users, including faculty and learners, be satisfied with their simulation experiences. On occasions when that satisfaction is not achieved, all simulation users will have an opportunity to register a complaint with the intent of allowing the Center to provide an appropriate remedy. DEFINITION: Simulation Faculty – Includes instructors, facilitators, on-site content experts, simulation technologists, simulation technicians and simulator operators who have a direct role in providing the educational experience for the learners. PROCEDURE/GUIDELINE: Simulation Faculty Complaints Scheduling: Simulation Faculty complaints concerning difficulty in scheduling a room, equipment, or other resources should be addressed to the Center Manager. The Manager can often identify alternative arrangements that are satisfactory. Users may also raise these concerns directly with the Director. Room Setting or Equipment: Concerns relating to satisfaction with the rooms or equipment provided for a particular session should be immediately communicated to the technologist(s)/technicians(s) supporting the session or the Center Manager. Users may also raise these concerns directly with the Director.

Simulation Faculty Satisfaction Survey: Faculty are encouraged to complete the electronic Faculty Satisfaction Survey - http://www.surveymonkey.com/s/SimulationSatisfaction. This electronic form provides an opportunity to assess different aspects of the session, including session support and planning that preceded the session. Surveys are available on several hallway computers. Access to the information provided is strictly controlled and reviewed only by the Center Director, Manager, and Lead Simulation Technologist. Learner Complaints Learners are provided opportunities to share feedback in most simulation sessions in which they participate. Complaints usually focus on learning objectives and curriculum, which are best directed to Departmental contacts. Learner complaints that relate to Sim Center equipment, facility, or staff support, should be communicated to the Center Manager or Director. If the learner would like his/her complaint to be confidential, he/she can complete an electronic satisfaction survey on the hallway computer, and identify themselves as a learner. REFERENCES: None PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-5002 Complaint Resolution Effective: July 2013

http://www.surveymonkey.com/s/SimulationSatisfaction

Research Mission Statement


Original: Effective: April 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: Research conducted at the Penn State Hershey Clinical Simulation Center shall be of sound design and advance the mission of the Penn State Hershey Medical Center Strategic Plan. DEFINITION: The mission of the Penn State Hershey Clinical Simulation Center is to improve patient outcomes with effective programs that promote and enhance practitioner skills, clinical competence, teamwork, and interdisciplinary collaboration. To advance the field of healthcare simulation, the Center conducts innovative research into simulation theory, practice, and technology.

PROCEDURE/GUIDELINE: This policy applies to all research conducted within the Center and /or with support of Center investigators, staff, facilities or equipment. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 1. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-6000 Research Mission Statement Effective: April 2013

Research Committee and Meetings



PURPOSE: This forum will serve as a resource for the investigative team by reviewing newly proposed and ongoing research for updates and approval and to support and encourage innovative research using simulation. DEFINITION: Research conducted in the Penn State Hershey Clinical Simulation Center is overseen and reviewed by the Research Committee, chaired by the Center’s Director of Research. Research Committee meetings are held quarterly (minimum of 4 times/year) and are open to all interested researchers. In addition, the Director of Clinical Simulation, the Director of Research, and the Manager of the Center will meet as needed to review research projects. PROCEDURE/GUIDELINE: The standing members of the Research Committee include 1) The Director of Clinical Simulation, 2) the Director of Research, 3) the Manager of the Simulation Center, 4) the Director of Simulation Education, and 5) the Research Coordinators. Responsibilities of the Research Committee include: 1. Review the merits of proposed simulation-based research projects and make suggestions regarding protocol amendments to the initiating investigator 2. Ensure that research conducted is scientifically and ethically sound in accordance with simulation best practice 3. Act as a resource for developing solutions for delayed progress 4. Monitor productivity of research 5. Actively support simulation-based research to promote, review and assist the submission and presentation of research conducted at the Simulation Center at local, regional, national or international forums, and for peer-review publication 6. Develop skills of novice researchers through mentoring and support 7. Act as a resource for posting current status of projects, presentations, publications, and grants

REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 1. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 3. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: -----

Revised: 26Nov2013 Clinical Simulation Center Policy Manual Policy Number: SIM-6001 Research Committee and Meetings Effective: April 2013

Research Investigator and Personnel Requirements



PURPOSE: To ensure that all research investigators and personnel are properly qualified and trained to perform all procedures that apply to research conducted within the Simulation Center and/or with support of Center investigators, staff, facilities or equipment. DEFINITION: All sponsored projects at The Penn State Hershey Medical Center must have an individual designated as Principal investigator, (PI), who has sufficient authority; appropriate background, knowledge, training, and accountability to carry out all aspects of the project including assumption of fiscal responsibility; and is qualified under the eligibility guidelines herein. If requested, The Center Research Committee will assist the principal investigator (PI) in determining if the research activities are within the scope and level of training and expertise of the investigators and personnel.

PROCEDURE/GUIDELINE: Please refer to HSPO Human Research Protection Requirements (November 2011) http://www.pennstatehershey.org/c/document_library/get_file?uuid=39115f7f-087d-45ab-9cdd-776d3447bc06&groupId=401341 REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 2, d, i. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

http://www.pennstatehershey.org/c/document_library/get_file?uuid=39115f7f-087d-45ab-9cdd-776d3447bc06&groupId=401341

http://www.pennstatehershey.org/c/document_library/get_file?uuid=39115f7f-087d-45ab-9cdd-776d3447bc06&groupId=401341


Clinical Simulation Center Policy Manual Policy Number: SIM-6002 Research Investigator and Personnel Requirements Effective: April 2013

Research Program Assessment



PURPOSE: Assessment tools allow program administrators and investigators to examine which aspects of the Research Program require improvement. The Penn State Hershey Clinical Simulation Center promotes the belief that high quality research programs are reflective and willing to improve, change, and grow. Outcomes will be measured and used for ongoing program planning, improvement, and evaluation.

DEFINITION: The Penn State Hershey Clinical Simulation Center utilizes various assessment tools to evaluate the effectiveness and quality of the research program. Tools have been developed to help programs be reflective, to pinpoint strengths and weaknesses, and to target areas for improvement. PROCEDURE/GUIDELINE: The Penn State Hershey Clinical Simulation Center Research Program has recognized eight essential elements that define effective and quality research:

1. Environment/Climate: Safe, healthy, and nurturing environment for all researchers and Participants

2. Administration/Organization: Well-developed infrastructure and sound fiscal management to support and enhance worthwhile research activities for all researchers

3. Relationships: Develops, nurtures, and maintains positive relationships and interactions among staff, researchers and collaborators to support the program’s goals

4. Staffing/Professional Development: Recruits, hires and trains diverse staff and investigators who value each participant, understand their developmental needs, and work closely with administration, staff, researchers and collaborative partners to achieve the program goals

5. Administration/Researcher/Collaborative Partnerships: Establish a strong partnership with research communities in order to achieve program goals

6. Program Sustainability/Growth: A coherent vision, mission and a plan for increasing capacity that supplies continuing growth

7. Measuring Outcomes/Evaluation: A system for measuring outcomes and using that information for ongoing program planning, improvement and evaluation

8. Dissemination of Information: Ability to interpret study results and present them in a scientifically sound, unbiased and timely manner to the greater research community through local, regional , national and international conferences and peer-reviewed publications.

This applies to all research conducted within Penn State Hershey Clinical Simulation Center and/or with support of the centers investigators, staff, facilities or equipment. The Center Research Program evaluates and assesses its effectiveness on the following levels: 1. Program evaluation: Includes both process evaluation and outcomes evaluation, achieved through:

a. Annual Executive review of all research study activity

2. Process evaluation: Assess whether a program is designed and implemented as intended, achieved through:

a. Research Meetings - investigator presentation of specific research studies b. Mentor review/discussion

3. Outcome evaluations: Assess a program’s success in reaching its goals and research objectives, achieved through:

a. Program Support Satisfaction Survey: Each Investigator will be asked to complete a brief electronic survey to assess the quality of the Simulation Center’s support for the research project. This survey includes planning, room preparation and setup, and staff support. b. Publication output

4. Program quality assessment tools refer to assess the different criteria, standards, or models that are used to components that comprise “quality”, achieved through:

a. Compliance with PSHMC IRB rules and regulations b. Compliance with FDA reviews, as required c. Obtaining funding through competitive grants

d. Peer-reviewed presentations accepted at local, national and international meetings e. Peer-reviewed publications f. Internal and external invited peer reviews of programs (e.g. visiting professors, mock

and real accreditation reviews) REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 2, b, i, ii, & iii. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-6003 Research Program Assessment Effective: April 2013

Data Storage and Integrity Policy



PURPOSE: To ensure that all research data is kept in accordance with Penn State Hershey Medical Center regulatory requirements as indicated in each Institutional Review Board (IRB)-approved protocol consistent with the Human Subject Protection Office (HSPO). DEFINITION: It is the policy of the Penn State University College of Medicine (PSU) Institutional Review Board (IRB) to review the data security and integrity plans for all research studies involving human subjects to ensure the protection of confidential information of research participants and to ensure the integrity of the data. PROCEDURE/GUIDELINE: Please refer to HSPO Policy-Security and Integrity of Research Data (January 2012) http://www.pennstatehershey.org/c/document_library/get_file?uuid=737a54ec-e787-43d6-9cf1-13fa99af7fa7&groupId=401341 REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 5, b, i. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-6004 Data Storage and Integrity Policy Effective: April 2013

http://www.pennstatehershey.org/c/document_library/get_file?uuid=737a54ec-e787-43d6-9cf1-13fa99af7fa7&groupId=401341

http://www.pennstatehershey.org/c/document_library/get_file?uuid=737a54ec-e787-43d6-9cf1-13fa99af7fa7&groupId=401341

Regulatory Document Management



PURPOSE: It is the policy of the Penn State Hershey Clinical Simulation Center that all research study regulatory documents will be kept in accordance with IRB and HSPO protocols. All regulatory essential documents shall be maintained and monitored by the Principal Investigator (PI). Research documents must be made available to the Research Committee as needed. DEFINITION: The PI is responsible for the oversight and management of the essential documents of a research study and ensures that the documents demonstrate compliance with the approved protocols, institutional policies, and applicable regulatory requirements. The PI may delegate the day-to-day responsibility of essential documents to other members of the study team. PROCEDURE/GUIDELINE: REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 5, b, ii. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-6005 Regulatory Document Management Effective: April 2013

Research Process Policy



PURPOSE: To provide an organized, systematic process for research development and implementation in the simulation center. DEFINITION: Research coordinated and conducted within the Penn State Hershey Clinical Simulation Center is carried out according to applicable Penn State Hershey Medical Center/College of Medicine (PSHMC/COM) research institute policies. Because the mission of the institution addresses research: training assessment, technology validation, educational methodology assessment, competency assessment, and development of future researchers, the daily operations of the Simulation Center run parallel and are directly linked to the research initiatives. The Simulation Center complies with all applicable federal policy statements. PROCEDURE/GUIDELINE: Primary Investigator should complete Research Proposal Form

1. Those interested in conducting research should complete the Penn State Hershey Clinical Simulation Research Proposal Form which can be found on our website at http://www.pennstatehershey.org/web/simulation/home/research. The form should be completed by the research team (protocols, IRB submissions can be attached where applicable). After form completion the form should be sent electronically via the simulation center dropbox.

• Location of the Drop Box: The Simulation Center Research Drop Box is in the Sim Center departmental folder on the HersheyMed network. Access the HersheyMed network at \\hersheymed.net\files (or via this icon available on most Hershey campus computer desktops).

• Create a separate folder: On your computer create a new folder and put your submission documents in it. With your cursor pointed at your desktop, ‘Right click’ and select New, then Folder. Include the Investigator name and date in the

http://www.pennstatehershey.org/web/simulation/home/research

name (Ex. Mulvey21March2013.).

• Use Right Click, Copy & Paste to add files to your folder. Provide the Word version of the file. Copy to Drop Box: Right Click on your submission folder to Copy & Paste the entire folder to the Sim Center Drop Box.

2. Schedule a meeting with a Simulation Center technologist to determine needs (equipment, manikin, space requirements, etc.) for the project by calling the Simulation Center at (717)531-4099.

3. The Research Coordinator will contact you to schedule a presentation at a Research Committee Meeting to determine feasibility, resources, and prioritization.

4. The study team will present an update on the research progress to the Research Committee within the first 12 months of data collection to ensure that the study is meeting its timeline and research objectives.

5. If there is any interest in publishing research projects from data collected at the Simulation Center, in any form, the investigator must have approval from the Penn State Hershey Medical Center’s Institutional Review Board, (IRB).

REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Research Standards, Section 2, b, i. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager. Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-6006 Research Process Policy Effective: April 2013

Confidentiality



PURPOSE: Assuring confidentiality regarding the performance of learners and simulation participants is key to creating a safe learning environment. Center learners must be confident that their performance will not be shared beyond those who need to know. When examining how simulation is used, there are two areas to be aware on why confidentiality is important: Learning Simulations – One of the uses of simulation is to push learners to the limits of their knowledge and capabilities in order for them to stretch and gain new knowledge and skills. This type of situation may generate mistakes. These mistakes can be excellent learning opportunities. However, learners must feel comfortable pushing themselves to this level and know that these mistakes will not be shared outside the simulation room with individuals who do not have a need to know. Assessment Simulations – Assessments are often part of a learner’s grade or can indicate readiness for promotion or advancement. As part of the Penn State University system, the Center and its faculty have responsibilities to maintain privacy of records relating to student performance. This expectation of privacy will extend to all Center learners who undergo assessment simulations. DEFINITION: None

PROCEDURE/GUIDELINE: Center learners should be advised of the expectation of confidentiality at the beginning of a simulation scenario or at the beginning of a series of simulation if the learning experience is a longer course. Each learner has a role in maintaining this confidentiality and the expectation will be made that learners should not discuss performance of other learners in the simulation session beyond the session itself. This applies to all simulations, both for learning and assessment. Specific requirements are in place for assessment simulations. For all Penn State students participating in an assessment simulation, PSU Policy AD11 University Policy on Confidentiality of Student Records will apply. (http://guru.psu.edu/policies/AD11.html) Records pertaining to either formative or summative simulation performance, including either video or paper records, will be kept secure. Video records will be kept on a secure server with controlled access from the simulation staff as stated in Simulation Policy SIM-8002 Video Recording and Privacy. Paper records including scoring checklists and other assessment tools will be kept secure by means of locked storage. It is the responsibility of the individual faculty member or staff assigned to each course to see that this occurs. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, f, iii. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 6, b, I, ii, & iii. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center

Reviewed: -----

Revised: -----

Clinical Simulation Center Policy Manual Policy Number: SIM-7001 Confidentiality Effective: July 2013

http://guru.psu.edu/policies/AD11.html

Psychological and Physical Safety



PURPOSE: Simulation scenarios designed to pose challenges to clinicians, are likely to generate some level of performance anxiety on the part of participants. Even if the goal is explicitly learning and not “testing,” certain factors of simulation potentially provoke anxiety in nearly everyone, and in some, potentially severe anxiety. Contributing factors include the ability to generate challenging situations that might not be seen on a routine basis, the ability to record performance and review it, and presence of peers working together to review the recordings together. These factors can lead to feelings of stress, anxiety, and even incompetence. Faculty, instructors, facilitators, technologists, technicians, and operators need to be aware of the impact of these stressors on learners and recognize when these stresses may become a threat to the patient’s psychological safety.

Additionally, certain aspects of simulation may pose a physical threat to learner safety. Activities such as defibrillator use, inserting IV or IO needles, and moving heavy manikins or equipment may produce threats to learner safety. DEFINITION: Simulation Faculty – Includes instructors, facilitators, on-site content experts, simulation technologists/technicians, and simulator operators who have a direct role in providing the educational experience for the learners. PROCEDURE/GUIDELINE: The Center requests that Simulation Faculty promote sound simulation principles, including a commitment to:

• Maintain confidentiality regarding the performance of specific individuals and the details of simulation sessions.

• Treat participants as intelligent, well-trained, and committed to improving. • Encourage a culture of respect among the session participants. • Lead an explicit discussion of principles and rules for behavior during simulations and in

debriefing. These emphasize the use of non-judgmental communication, constructive critique, a focus on the performance, not the performer, and the strict confidentiality of simulation activity.

For any learner who exhibits signs or symptoms of psychological stress, Simulation Faculty will escort the individual to a quiet area. The hospital Chaplain (pager 1253) will be notified. The participant will be provided with phone numbers for the EAP Program and the Employee Health Office. If the individual chooses to proceed to a location outside the Simulation Center, staff will provide an escort, if requested. To maintain physical safety, faculty, instructors, facilitators, technologists, technicians, and operators must ensure learner actions are done in a manner that is safe to both themselves and their fellow learners. Two areas that must be continuously monitored are and may require direct intervention by faculty, instructors, facilitators, technologists, technicians, or operators are safe use of electrical therapy and handling and disposal of sharps. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2, f, iv. PERSON RESPONSIBLE FOR REVIEW OF POLICY:

Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-7002 Psychological and Physical Safety Effective: July 2013

Medical Emergencies



PURPOSE: Medical emergencies are unpredictable and may occur in any location. As a medical center with internal emergency care capabilities, medical emergencies at PSHMC must be managed in a manner that provides the most suitable care, including screening and transport to appropriate locations. DEFINITION: Life Threatening Condition – Any condition that poses a threat to patient life or limb, including but not limited to: Cardiac arrest, respiratory arrest, unresponsiveness, seizures, severe respiratory distress, chest pain, cardiac dysrhythmia, anaphylaxis, severe trauma or burns, heat stroke, CVA, or emergency childbirth. High-Level Condition – Any condition that may develop into a life threatening condition, included but not limited to: Mild shortness of breath, minor trauma or burns, non-cardiac chest pain, abdominal pain, nausea, diabetic emergencies, fractures, or lacerations. Minor Injury or Condition – Any condition that does pose an immediate or developing threat to life or limb, including but not limited to: Skin rash, flu-like symptoms, dizziness, general illness, weakness, minor cuts and scrapes, bruises, or headache. PROCEDURE/GUIDELINE: 1. Life Threatening Condition Immediately activate the emergency response system by calling 8888. If cardiac arrest is suspected, send someone to retrieve an AED (one outside Main Library entrance on 1st floor or

on 1st or 3rd floor of BMR by west elevators). Request assistance from providers who are in the Simulation Center and initiate basic life support measures until help arrives. 2. High Level Condition The individual, if ambulatory, should be accompanied to the Emergency Department. If not ambulatory, activate the emergency response system by calling 8888. 3. Minor Injury or Condition Employees should be accompanied to the Employee Health Service; non-employees to be accompanied to the Emergency Room.

Incident Report Should staff, faculty, or learners be injured in the Sim Center, staff will complete and file an incident report to submit to the Center Manager who will then forward to the Department of Risk Management.

Incident Report \\hersheymed.net\files\SIMCenter\Public\Policies\Financial and Administrative\GuidelineAttachments\IncidentReport.docx When calling 8888, be prepared to provide the following information:

• Your name and exact location • The type of emergency • The condition of the ill or injured person

REFERENCES: None PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-7003 Medical Emergencies Effective: July 2013

Non-Medical Emergencies



PURPOSE: PSHMC requires all departments to have an Emergency Operations Plan. This policy, combined with Policy SIM-7003 Medical Emergencies, covers the components of an Emergency Operations Plan for the PSHMC Clinical Simulation Center. DEFINITION: None PROCEDURE/GUIDELINE: All Campus Emergencies 8888 Non-Emergency - Security 8711 Non-Emergency - BOC 8096 Department Director (Lisa Sinz, MD) (717) 602-3021 – Cell Department Manager (David Rodgers) (304) 444-1078 – Cell Safety Officer Department of Safety 7297 A. Fires Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf A. Dial 8888 to report a fire - Do not shout “FIRE”. B. Staff should know the location of FIRE ALARM PULL STATIONS in their unit:

The pull stations are located in the following areas:

http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf


• Stairwell 4 doorway (Penn State Faculty Lounge Lobby) • Stairwell 6 doorway (near Classrooms A/B)

C. Staff should know the location of FIRE EXTINGUISHERS IN THEIR UNIT: The fire extinguishers are located by:

• Study area lobby by computer classroom • Outside Manager’s office (C2624) • Training Room 5 Hallway, close to Training Room 6 • Bay Control Room near staff office (C2630D) • SP Control Room

D. All corridors should be cleared of all obstructions in preparation for evacuation. E. A fire alarm will only activate in the affected building. F. Do not enter the building if the fire alarm is activated. G. Do not use the building elevators. H. The “All Clear” is when the fire alarm stops. Fire Procedures If you discover a fire: R.A.C.E. is required!

• Rescue persons in immediate danger to safety. • Alarm the area by pulling the nearest fire alarm box AND dial 8888. • Confine the fire and smoke by closing all doors and windows. • Extinguish/Evacuate – If you have been trained and can do so safely, extinguish

the fire with a fire extinguisher and follow your dept/unit evacuation plan. B. Medical Gas or Simulated Medical Gas Failure The Center utilizes both actual medical gases supplied via a tank system and simulated medical gases supplied by a compressed air generator. In the event of a leak or actual fire in a room, these systems must be shut off. All Center staff are authorized to shut off the system in the event of an emergency. The Bay area of the center is supplied with oxygen, nitrous oxide, carbon dioxide, and nitrogen from a tank system. Simulated medical air area is supplied with compressed air from the compressor system. There is an emergency shut off valve system located in the Bay area control room. The compressed air system supplies the Training Room area with simulated air and oxygen. This air system can be shut off by the valve in the Bay area. There are a supplemental shut off valves that can isolate Training Rooms 1 through 4 outside of the Debriefing Room and a

separate shut off valve that can isolate Training Rooms 5 through 10 located near Training Room 5. C. Utility Failure Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf D. Failure of the Simulated Medical Gas System Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf E. Terrorism Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf F. Epidemic Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf G. Mass Casualty Incidents Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf H. Severe Weather, Tornado (High Winds), & Geological Events Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf I. Information System Failure Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf J. Internal Flood Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf

















K. Internal Hazardous Materials and Chemical Exposure Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf Hazardous Material Spill:

1. Evacuate personnel from the spill area and alert all people in the vicinity of the spill. 2. If there is anyone who may have been contaminated by the spill, they should avoid any contact with others and remain in the immediate area so required first aid and decontamination can be done upon the arrival of emergency personnel. Use safety showers immediately if appropriate. 3. Call 8888 from a safe location. Be specific about the nature of the spilled material, if known, and the exact location. 4. Isolate the spill area and close doors to the room where the spill occurred if it is safe to do so.

L. Nuclear Incident Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf M. Facility Evacuation Protocol Follow the institutional specific Emergency Protocols located at: http://infonet.hmc.psu.edu/eop/Quick%20Emergency%20Incident%20Reference%20Guidelines%206_20_12a.pdf N. Bomb Threat Follow procedure in Security policy : #9-11. O. Child Abduction Follow procedure in with the Infant Abduction policy located at: http://infonet.hmc.psu.edu/security/infant/index.htm P. Weather Emergency Follow the procedure in Hospital Administration policy: HAM #A-11. Q. Workplace Violence Follow the procedure in Hospital Administration policy: HAM #A-50. R. Power Failure







http://infonet.hmc.psu.edu/security/infant/index.htm

1. All hot work should cease immediately and not be left unattended until surfaces have cooled to a safe temperature. 2. Any machinery and equipment in use should be switched to the OFF position to prevent unexpected or sudden start up when power is restored. This does not apply to refrigerators and freezers. 3. Turn off all light switches. The voltage may fluctuate and damage any lights that are on. 4. Set all equipment and appliance switches to the OFF position. This is to protect against kicking out the circuit breakers, blowing fuses, or damaging equipment when the full surge or current hits as the power comes back on. 5. If it becomes necessary to evacuate the premises during a power failure, be sure to protect all valuables and make sure that all equipment is safe when the power comes back on. 6. When there is a power failure, do not use the elevator. It may become inoperative.

REFERENCES: Institutional Emergency Operations Plan The institutional emergency operations plan is located on the infonet: http://infonet.hmc.psu.edu/eop/Emergency_Operations_Plan.pdf PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-7004 Non-Medical Emergencies Effective: July 2013

http://infonet.hmc.psu.edu/eop/Emergency_Operations_Plan.pdf

Video Recording and Privacy


Original: March 2012 Effective: July 2013 Authorized: Elizabeth Sinz, MD Director, Clinical Simulation Center Approved: David Rodgers, EdD, EMT-P Manager, Clinical Simulation Center

PURPOSE: Recording of audio and video learner performance is required for either review of training experiences in a formal debriefing setting or for documentation of summative assessments such as OSCE sessions as part of the learner’s record. Security and maintenance of privacy of those recordings is paramount. DEFINITION: None PROCEDURE/GUIDELINE: While the Center has installed cameras in nearly every room, it protects the privacy of users by:

1. placing notices reminding users that cameras are present 2. recording only when requested by session faculty or meeting organizers 3. permitting only authorized individuals to view live room videos or view sessions through

one-way glass Authorized individuals are those who are session instructors or have other direct oversight for the sessions they observe. Learners participating in sessions that are recorded are informed that the resulting videos can be used only by their faculty and only for educational purposes. Further, they are assured that use of video by other faculty or learners, even if for educational purposes, is prohibited unless all participants in the recorded session sign a written release (below) to permit such use. Commercial use of recordings is not permitted.

The Center’s AV software restricts individuals from viewing videos unless assigned as faculty to the requested recorded session. Center staff will only download videos of specific sessions for faculty that were involved in those sessions.

A prerequisite for assuming personal possession of session videos (thumb drives, DVD’s, etc) is that every participant on the video must have a previously completed Video Release Form on file in the Simulation Center. With this form, individuals authorize the educational use only of recordings made of their simulation activity. Video Release Form \\hersheymed.net\files\SIMCenter\Public\Policies\Financial and Administrative\GuidelineAttachments\VideoReleaseForm.docx Retention and Archiving Unless otherwise requested, recorded videos are archived for three months and then deleted. Requests to extend the retention of specific videos should be addressed to the Manager of Operations. REFERENCES: Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 2,f, iii. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 6, b, i. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 6, b, ii. Society for Simulation in Healthcare, Accreditation Standards and Measurement Criteria (January, 2013) – Core Standards, Section 6, b, iii. PERSON RESPONSIBLE FOR REVIEW OF POLICY: Manager, Clinical Simulation Center


Clinical Simulation Center Policy Manual Policy Number: SIM-8002 Video Recording and Privacy Effective: July 2013

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